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Paleo Diet 8wk Feasibility in Overweight Adults

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University of Houston

Status

Completed

Conditions

Overweight and Obesity

Treatments

Other: Diet

Study type

Interventional

Funder types

Other

Identifiers

NCT03814473
STUDY00000104

Details and patient eligibility

About

Overweight, physically inactive but otherwise healthy adults habitually eating a traditional Western diet will follow an ad libitum self-administered Paleo diet for 8-weeks. Blood and body composition will be measured before and after the intervention period.

Full description

The Paleo diet is a dietary method that is gaining popularity among the general population due to potential weight loss and disease prevention benefits. The feasibility of the Paleo diet and the effectiveness of self-administration in improving cardiometabolic disease risk factors remains uncertain. Examination od cardiometabolic disease risk factors in overweight, physically inactive adults before and after 8-weeks of an ad libitum self-administered Paleo dietary intervention. Methods: Overweight, physically inactive but otherwise healthy adults habitually eating a traditional Western diet follow an ad libitum self-administered Paleo diet for 8-weeks. Blood samples were analyzed for fasting cardiometabolic disease biomarkers. Participants complete three-day dietary recalls prior to, and during weeks 4 and 8 of the intervention to confirm Western diet consumption at pre-, track compliance, and to assess dietary changes.

Enrollment

21 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age: 18-55 years
  • BMI > 25 kg/m2
  • Currently consuming a typical Western diet (high carbohydrate, low fat diet), which will be assessed using the 3-day dietary record (public domain)

Exclusion criteria

  • known cardiovascular, metabolic (including type I or type II diabetes), or respiratory disease
  • smoking and/or smokeless tobacco users
  • pregnancy

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

21 participants in 1 patient group

Dietary intervention
Experimental group
Description:
All participants will follow an ad libitum self-administered Paleo diet for 8-weeks
Treatment:
Other: Diet

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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